Recruiting

Non-Nutritive Sweetener

Sponsor:

Medical College of Wisconsin

Code:

NCT07434544

Conditions

Non-Nutritive Sweetener

Type 1 Diabetes

type1diabetes

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

Cherry Sports Drink

Study Details

Brief summary:

This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes.

Conditions

Non-Nutritive Sweetener

Type 1 Diabetes

type1diabetes

Type 1 Diabetes Mellitus

Study ID

NCT07434544

Start date

Aug 5, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 15-24 years
2. Clinical diagnosis of type 1 diabetes, requiring insulin therapy, of ≥ 1 to < 10 years duration.
3. Last available HbA1c ≤ 8.5% (obtained by chart review in Children's Wisconsin Diabetes Clinic patients or verbally by individuals not receiving diabetes care at Children's Wisconsin)
4. Current use of an FDA approved automated insulin delivery (AID) system
5. Willing to consume a 12 ounce Gatorade G Zero Glacier Cherry drink in less than 10 minutes
6. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age

Exclusion Criteria:

1. Any disease other than type 1 diabetes that affects glucose, sex steroid, or fat metabolism such as polycystic ovary syndrome or hypercortisolism
2. Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids
3. Half or full sibling already participating in this study
4. Known cardiovascular disease such as hypertension or atherosclerosis, and/or use of an anti-hypertensive medication
5. Known hyperlipidemia, defined as LDL ≥ 160 mg/dL, and/or use of lipid-lowering medication, such as statin therapy
6. Known renal disease or microalbuminuria, and/or use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARBs) for microalbuminuria
7. Known diabetic retinopathy or neuropathy
8. Raynaud's phenomenon or other vascular disease
9. Obesity and/or body habitus that precludes completion of the flow-mediated brachial ultrasound study (generally, BMI > 40 kg/m2 in adults) - this is at study team's discretion.
10. Pregnancy or lactation
11. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Sports Drink - Participants will drink a cherry sports drink within 10 minutes.

Interventions

Cherry Sports Drink

12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink

Primary outcome measure

  • Change in "in vivo" endothelial function and vascular stiffness [ Time Frame: 2 years (duration of study) ]

Central Contacts and Locations

Central contacts

Susanne M Cabrera, MD

414-955-4903T1dinfo@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Susanne M Cabrera, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Non-Nutritive Sweeteners
  • Type 1 Diabetes
  • Cardiometabolic
  • Long standing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.